1. Field of the Invention
The present invention is related to a process of making lapatinib, salts and novel intermediates thereof
Lapatinib has the structural formula (I) and chemical name N-[3-chloro-4-[(3-fluorophenyl) methoxy]phenyl]-6-[5-[(2-methylsulfonylethylamino)methyl]-2-furyl]quinazolin-4-amine.

Lapatinib is an orally administered small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, used in the form of ditosylate salt to treat advanced or metastatic breast cancer and other solid tumors which were treated by Anthracyclines, Taxanes and Trastuzumab (Herceptin®). Lapatinib ditosylate was approved by the FDA in 2007 and the EMEA in 2008 and is marketed by GlaxoSmithKline (GSK) under the trade name of Tykerb® in the USA and Tyverb® in Europe.
There is a need for an improved process of making lapatinib and its pharmaceutically acceptable salts.